However, the “About Other Allergens” section, where FDA advises consumers to “read the food label’s ingredient list carefully to avoid the food allergens in question” is both disingenuous and dangerously misleading.

FDA is well aware that consumers with allergies not covered under the FALCPA do “not receive sufficient information from food labels to protect their safety”. (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 109 (2006).)

The FDA, at this time, does not regulate corn to the extent that it does, say, peanuts, so we corn allergy sufferers are truly on our own.

You think that advice to just read the label helped much? At least give them/us a fighting chance with a little better education, if not better allergen regulation. Let's minimize the amount of "learning" that consumers/patients are doing the hard way by having reactions.

We've patiently waited and watched for years, hoping that a major allergy organization would act on this issue (to get sesame labeled in the USA). They have the resources - $, expert allergists, lawyers, connections, regulatory experience - to do this the right way. We didn't want to make things worse for the allergy community by pushing ahead without their support.

However, at this point, we FASers are seriously considering submitting a petition ourselves. As a group, we have many talents (some of us are good at writing, some have a scientific/medical background, we understand the law pretty well thanks to FDLI (A special to James Kelly - I will never forget his kindness), some are extremely persistent , some can get feedback for refinements before submitting, etc.). We have also reached out to people outside our group who have the (respected/likeability/social media/good image) qualities that we sometimes fall short on - some are already on board if we should move forward.

Soooooo .... this is the time to communicate with us if there is a good reason why we should hold off on doing this. We are really hoping that one of you allergy orgs will save us a lot of work.

We are willing to work together with any of the main allergy orgs on this.

1) The 2005 Policy Advisor to CFSAN’s Director of the Office of Regulations and Policy stated that “We’ve got enough to deal with right now with the eight major allergens.” (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 141 (2006).)

And we don't have enough to deal with? Sheesh. Clearly these people are not living with sesame allergy.

Now I'm regretting not sending several products to FAARP. There was a flatbread and other breads. My sesame reactions have gotten worse, so in not inclined to buy things to try them out just to see if they're okay.

1) The 2005 Policy Advisor to CFSAN’s Director of the Office of Regulations and Policy stated that “We’ve got enough to deal with right now with the eight major allergens.” (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 141 (2006).)

And we don't have enough to deal with? Sheesh. Clearly these people are not living with sesame allergy.

Sesame is an allergen that appears to be increasing in prevalence, and FARE has received questions before about what is needed to update a “top allergen” list. More research studies would need to be done that confirm any other allergens outside the currently recognized Top 8 have enough prevalence in order to be added, and we have no information that leads us to believe such a change will be taking place in the very near future.

Definition of Tree Nuts Should be ReviewedWe would also request that FDA review comments regarding the list of tree nuts included in the Q&A document, previously submitted by Grocery Manufacturers Association to Docket No. 2005D-0490 on May 14, 2007. These comments identified some concerns with categorizing ten nuts including coconut as a major food allergen, due to the botanical classification and the lack of incidence of severe allergic reactions. IDFA strongly agrees with GMA’s comments that review of the scientific literature establishes there are insufficient data to support the inclusion of beech nut, butternut, chinquapin, ginkgo nut, hickory nut, pili nut, sheanut, chestnut, coconut, and lichee nut in a list of major food allergens. Inclusions of “tree nuts” that have either no history of sensitization and elicitation of allergic reactions (beech nut, butternut, chinquapin, ginkgo nut, hickory nut, pili nut, and sheanut), or only a few cases of mild and non-life threatening reactions (chestnut, coconut, and lichee nut) contradict the intent of FALCPA and leads to an unnecessary elimination of food choices that are enjoyable, nutritious and convenient to allergic consumers

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Really, I'm done talking to the FDA. I'm not a good talker anyway.

For matters like this, I much prefer written communication.

I don't know, I just feel like it's time to make a decision, one way or the other ... do we do this or not? Eventually (maybe in like 10 or 15 years ) sesame will probably get added without our FAS involvement if we decide to drop the issue. You all know that I'm personally fine at this point with whatever we decide. I would give my allergist a chance to talk us out of this also.

Request of Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds

FDA-2012-N-0711-0053

Quote

The decisions should be based upon science.

This is not directed at anybody in particular (just speaking in general terms):

Yes, the decisions should be based on science ..... but let us not forget the real people that are unnecessarily at an increased risk of having a severe allergic reaction because of inadequate labeling. Do not get too detached from the faces behind the science.

How many people at risk does it take to justify labeling for an allergen?